Kornimate/medical-research-clean huggingface dataset:
a study of tirzepatide in chinese participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to learn more about the safety and side effects of tirzepatide in chinese participants with type 2 diabetes mellitus. the study will also measure how much tirzepatide gets into the bloodstream and how long it takes the body to remove it. the study will last about six or eight months for each participant.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm) controlled with diet and exercise alone or are stable on a single oral antihyperglycemic medication (oam), metformin, acarbose, or sulphonylureas only (other types of oam \[dipeptidyl peptidase iv inhibitors, sodium-glucose cotransporter-2 inhibitors, and thiazolidinediones\] are not allowed in this study), for at least 3 months * have a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²), inclusive exclusion criteria: * have type 1 diabetes mellitus * have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to visit 1 * have a history of heart block or pr interval greater than (\>)220 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ecg) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study * have a history or presence of pancreatitis or gastrointestinal (gi) disorder or a gi disease that impacts gastric emptying or could be aggravated by glucagon-like peptide-1 (glp-1) analogs or dipeptidyl peptidase iv (dpp-iv) inhibitors * have known allergies to tirzepatide, glp-1 analogs, or related compounds or any components of the formulation
first trimester screening for trisomy 21, 18, 13 and 22q11.2 deletion syndrome

Conditions: Pregnancy

Summary: combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. the concept is based on the age risk, the measurement of fetal nuchal translucency (nt), and the determination of serum markers free beta-hcg and papp-a in maternal blood. in recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free dna analysis from maternal blood. in their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. no normal fetus displayed an increased risk. in contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. in this study the investigator examine the test quality - especially the false positives - of cell-free dna analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.


Eligibility criteria:
inclusion criteria: * maternal age of 18 years and more * crown rump length 45 - 84mm * referral for first trimester risk assessment * singleton pregnancy * written consent exclusion criteria: * no consent * known parental microdeletion 22q11.2 * crown rump length \ 84mm * multiple pregnancies including vanishing twins
a study to test once-weekly doses of odanacatib (mk0822) on healthy adult females (0822-005)(completed)

Conditions: Osteoporosis

Summary: this study will assess the safety, tolerability, pk, and pd of a once weekly dose of mk0822 in healthy postmenopausal women.


Eligibility criteria:
inclusion criteria: * subject is less than or equal to 75 years of age * subject is a postmenopausal female * subject is within 30% of ideal body weight * subject is judged to be in good health * subject is a nonsmoker * subject is willing to avoid excessive alcohol consumption for the duration of the study * subject is willing to avoid strenuous physical activity for the duration of the study * subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study exclusion criteria: * subject has a history of multiple/severe allergies to foods or drugs * subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study * subject has a history of major gi abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases * subject has a history of bone disease or treatment with bisphosphonates * subject has an infection/condition that would suppress the immune system, including hiv * subject has a history of chronic/active hepatic (liver) disease, including hepatitis b and c * subject regularly uses illegal drugs * subject consumes more than 3 alcoholic beverages per day * subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day * subject requires use of any prescription or non-prescription medications during the study * part i only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; glucocorticoid treatment; vitamin a greater than 10,000 u/day, vitamin d greater than 2000 u/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.
immune and scfa profile of stunting children

Conditions: Immune Deficiency; Stunting; Fatty Acid

Summary: 1. type and research design a cross-sectional study design with a quantitative approach will be conducted. cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect). 2. time and location of research the research will be conducted for approximately six months in 2020 at banten regency (namely tegal ongok and pasirkarang) and sumedang regency. 3. population and research sample the population is children between three and five years old in the village of stunting locus. the sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each regency.

the variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, lbw, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist. stunting anthropometric measurements are measured based on parameters of length/height according to age compared to the who anthropometric standards 2005 and the indonesian minister of health decree no. 1995 / menkes / sk / xii / 2010. the nutritional status of each child included in this study will be quantified using the who recommended three nutritional z-scores namely, height for age (referred to in this study as zscore 1. weight for age (referred as z-score 2. and weight for height (referred as z-score 3. .a structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. in addition, age and anthropometric measurements (height, weight) based on the department of health ministry of indonesia the regulation will be recorded. for stunting, the thresholds for height-for-age are: 'severely stunted' (\ +3 sd). furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (\ +2 sd to +3 sd); 'obese' (\> +3 sd)

Eligibility criteria:
inclusion criteria: * children age : 3 - 5 years old (36-60 months) * live in the research area * apparently healthy children, after examination by a physician * involved in a research study (informed consent signed by parent or guardian) exclusion criteria: * children age \ 60 month * live outside research area * unhealthy, after examination by a physician

Keywords: immune status stunting normal nutritional status indonesian children gut microbiota scfa
safety and preliminary efficacy of the combination of niclosamide and camostat

Conditions: Covid19

Summary: niclosamide (2000 mg qd) and camostate (600 mg qid) are expected to be safe and well-tolerated as a combination therapy and to show clinically beneficial for covid-19 patients.

niclosamide is an approved drug for the treatment of intestinal worm infections that can potentially induce the process of autophagy and thus significantly limit viral replication in cells. camostat is approved in japan for the treatment of chronic pancreatitis and reflux esophagitis. it has been shown to effectively block viral replication in a sars-cov-2 animal model. since the mechanisms of actions are different, it was hypothesized that a combination of both substances might have an additive or even synergistic effect in the treatment of patients with covid-19. this study is designed to investigate the safety, tolerability and preliminary efficacy of the treatment combination niclosamide and camostat in mild and moderately affected covid-19 patients.

Eligibility criteria:
inclusion criteria: * male and female patients in the age of 18 to 70 years * having a recent positive direct test for sars-cov-2 * having mild or moderate covid-19 symptoms with no indication for hospitalization due to sars-cov-2 infection (who ordinal scale 1-2) exclusion criteria: * severe respiratory symptoms related to covid-19 requiring oxygen or intensive care (high flow oxygen or mechanical ventilation or ecmo) * patients with preexisting pulmonary diseases requiring oxygen supply * patients with history of hypersensitivity to camostat or niclosamide or to any ingredients to any of the two drugs * patients with heart failure (nyha iii or nyha iv) * patients with proven malignant tumor * patients diagnosed with influenza infection * pregnancy or breastfeeding * immunocompromised patients * creatinine clearance \< 60 ml/min * aspartate aminotransferase (ast) / alanine aminotransferase (alt) \> 2 times upper limit of normal (uln)
induction cisplatin and capecitabine followed by concurrent chemoradiotherapy for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: to prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with cisplatin and capecitabine followed by concurrent chemoradiotherapy (ccrt) in the treatment of locally advanced nasopharyngeal carcinoma.

all patients received 3 cycles of induction chemotherapy:cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy. intensity-modified radiotherapy (imrt) were used in all patients with the total dose and dose/fraction (fr) as follows: ptv (planned target volume)_1:70 grays (gy) at 2 gy/ fr, ptv_2:63 gy at 1.8 gy/ fr, ptv_3:56 gy at 1.6 gy/ fr;5 fractions per week. tumor response was evaluated after 3 cycles of induction chemotherapy and 16 weeks following completion of ccrt according to the response evaluation criteria in solid tumors 1.1 (recist1.1). all toxicities were gauged based on the common terminology criteria for adverse events version 4.03 (ctcae 4.03).

Eligibility criteria:
inclusion criteria: * pathological confirmed nasopharyngeal carcinoma. * staged as iii to ivb. * 18-75 years old. * performance status ≤2. * no previous chemotherapy or radiotherapy. * no concurrent malignancies or a history of other malignancies. * adequate bone marrow function (absolute neutrophil count ≥1.5×109/l, platelets ≥100×109/l). * adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min). * without serious co-morbidity. exclusion criteria: * stage i-ii or ivc. * allergic to cisplatin or capecitabine * age \ 75 * performance status \>2. * without adequate bone marrow or liver function or renal function. * severe co-morbidity and can not tolerate chemotherapy. * other conditions not suitable for the study on the discretion of charging doctor.

Keywords: nasopharyngeal carcinoma induction chemotherapy cisplatin capecitabine chemoradiotherapy
adverse effect of prolonged methylphenidate treatment on cardiac functions

Conditions: Attention Deficit Disorder With Hyperactivity; Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders With Hyperactivity; Attention Deficit Hyperactivity Disorders

Summary: the purpose of this study is to find out whether prolonged treatment with methylphenidate has any adverse effect on cardiac functions and measurements.

attention deficit hyperactivity disorder (adhd) is the most common neurobehavioral condition of childhood, with symptoms consisting of inattentiveness, impulsivity and hyperactivity. the diagnosis relies on subjective criteria since there is no objective test for adhd. stimulants are the recommended treatment, during the last 2 decades both the rate of its use has increased, and the age for starting treatment has decreased. adverse side effects have been few, none of which were serious. recently, regulators of the food and drug administration (fda) have been told on forty deaths among patients who took stimulants through 2003. accordingly, a subcommittee of the fda recommended that prescription drugs to treat adhd should be accompanied by strong 'black-box' warnings that they may increase the risk of heart problems in some patients. to date, there does not appear to have been any study that has evaluated cardiac functions in these patients. in this study we will evaluate the possible long term effect of methylphenidate on cardiac functions, as to provide more knowledgeable basis for decisions on the treatment of adhd patients with methylphenidate. children age 8-18 years who were treated on methylphenidate for more then five years will be allocated in outpatient clinics. complete ekg and echocardiographic examinations will be performed and cardiac functions, left ventricular mass and left ventricular muscle width will be compared to the normal range of values. the results will give us, for the first time, a basis to support or reject the causative relationship between these drugs and severe cardiac problems.

Eligibility criteria:
inclusion criteria: children with adhd aged 8-18 years who are taking methylphenydate (ritalin©, ritalin sr©, ritalin la©) for more than 5 years. exclusion criteria: children with any known heart disease or anomaly. children whose adhd is part of a syndrome or are mentally retarded. children that are on any other chronic medications.

Keywords: attention deficit disorder hyperactivity methylphenidate
adjunctive pimavanserin in subjects with major depressive disorder and inadequate response to antidepressant treatment

Conditions: Adjunctive Treatment of Major Depressive Disorder

Summary: to evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy

two separate studies, idential in design, were planned and initiated under 2 protocol ids and ncts, i.e. study acp-103-54 (nct03999918) and acp-103-059 (nct03968159). in march 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (covid-19) pandemic. at that point in time, about half of the planned patients had been randomized. the sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. as a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. no further patients were enrolled. this entry now includes the combined data of studies acp-103-054 and acp-103-059.

Eligibility criteria:
inclusion criteria: 1. adult patients, aged 18 years and above 2. a clinical diagnosis of major depressive disorder (mdd) 3. is being treated with one of the following ssri or snri antidepressants: 1. citalopram 2. escitalopram 3. paroxetine 4. fluoxetine 5. sertraline 6. duloxetine 7. venlafaxine 8. desvenlafaxine 9. venlafaxine xr 4. inadequate response to ssri/snri antidepressant treatment is confirmed 5. if the subject is female, she must not be pregnant or breastfeeding. she must also be of non-childbearing potential or must agree to use acceptable methods of contraception exclusion criteria: 1. has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder 2. has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program 3. has a known history or symptoms of long qt syndrome 4. is determined to be inappropriate for the study for any reason additional inclusion/exclusion criteria apply. patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
computerized decision support for identification and management of familial hypercholesterolemia

Conditions: Familial Hypercholesterolaemia

Summary: the goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called familial hypercholesterolemia. the main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder.

fh-alert is a single-center, time-series trial of a patient- and provider-facing epic bpa (alert-based cds tool) to increase diagnosis, ldl-c lowering, and guideline-based therapy of outpatients with presentations consistent with fh. for the first 6 months, the bpa will run in "silent mode", identifying patients with presentations consistent with fh, but not alerting the clinician of record. following this initial "pre-alert" 6-month period, the bpa will switch to "alert mode" for 18 months, which will provide the on-screen notification to the clinician of record. in other words, consecutive outpatients with presentations consistent with fh will be enrolled over two years: "pre-alert" (silent mode) for 6 months and "alert mode" for 18 months.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * seen in the bwh endocrinology, cardiovascular medicine, and primary care clinics * dutch lipid clinic network score of at least 3 points exclusion criteria: * a familial hypercholesterolemia diagnosis already documented in the ehr medical history, visit history, or problem list

Keywords: familial hypercholesterolemia computerized decision support electronic alerts high cholesterol
imaging on core muscles function in patients with visceral adiposity

Conditions: Obesity, Abdominal

Summary: the purpose of this study is to determine the effect of cavitation ultrasonic lipolysis, rusi guided core muscle exercise and their combination (cavitation ultrasonic lipolysis and rusi guided core muscles exercise) on diaphragmatic excursion, transverse abdominis activation ratio, visceral fat thickness and waist circumference in patients with visceral adiposity patients with visceral adiposity will be recognized by nutrition specialist. 45 patients were distributed randomly into three groups. the first group will be treated with cavitation lipolysis twice weekly. the second group was treated with rehabilitative ultrasound imaging (rusi) guided core muscle exercise. the third group was treated with combination of cavitation and rusi. patients will be examined with medical ultrasound imaging and tape measurement.

- inclusion criteria: forty five subjects participated in this study. age of participants ranged from 25 to 45 years. 3. waist circumference was more than 102 cm for men and 88 cm for women 4. body mass index (bmi) ranged from 25 to 29.9 (kg / m2). 5. subjects hadn't received drugs exclusion criteria: 1. history of spinal surgery or spinal fracture. 2. serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer. 3. a history of bronchial asthma or any chest disease. 4. uncontrolled diabetes or hypertension. 5. patients with peacemaker or any metal implant on the treated area. 6. cancer or patient with past history of tumor excision

Eligibility criteria:
inclusion criteria: * forty five subjects participated in this study. * age of participants ranged from 25 to 45 years. * waist circumference was more than 102 cm for men and 88 cm for women * body mass index (bmi) ranged from 25 to 29.9 (kg / m2). * subjects hadn't received drugs exclusion criteria: .history of spinal surgery or spinal fracture. * serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer. * a history of bronchial asthma or any chest disease. * uncontrolled diabetes or hypertension. * patients with peacemaker or any metal implant on the treated area. * cancer or patient with past history of tumor excision.